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FDA Purges NMN From the List of Supplements

The rationale is that it is being investigated as a drug.

NMN pillsNMN pills
 

Reversing its own earlier decision, the FDA has informed an NMN manufacturer that the molecule can no longer be marketed as part of dietary supplements. Another company that is testing NMN as a drug probably contributed to the decision, which is not being enforced as of now.

NAD and NMN

NAD+ is a multi-role coenzyme central to metabolism. It facilitates energy production in cells and acts as a substrate for important enzymes, such as sirtuins and PARP. NAD+ levels decline with age, contributing to multiple age-related diseases [1]. Studies have confirmed various health benefits of NAD+ supplementation in animal models [2], although human trials are scarce.

NAD+ levels can be boosted via its precursors, which include nicotinamide riboside (NR) and nicotinamide mononucleotide (NMN). NMN-containing supplements have been gaining popularity in the longevity community, even though not everyone agrees on their effectiveness or safety. NMN naturally occurs in foods such as edamame, broccoli, cabbage, cucumber, and avocado.

Allowed, then banned?

Considering NMN’s popularity, the news that the FDA has effectively banned its use in dietary supplements came as a shock, especially since this had nothing to do with the molecule’s efficacy or safety.

To market a compound in dietary supplements, a company must file a new dietary ingredient (NDI) notification with the FDA. Explicit approval is not required, but if the FDA raises objections, this precludes the compound from being used in supplements.

While NMN has been sold in some markets (mainly Japan) since at least 2014, it is a relative newcomer to the US. In the past two years, several companies have filed NDI notifications, and FDA did object to them on various grounds, mostly claiming that there is insufficient proof that NMN supplementation is safe.

In 2021-2022, new human NMN studies have been published [3], which might have alleviated FDA concerns. In May, the FDA acknowledged an amended NDI notification from the China-based company SyncoZymes without objections.

However, recently, responding to another NDI notification from the company Inner Mongolia Kingdomway, the FDA changed course and declared that ß-NMN (essentially NMN) cannot be marketed as a supplement due to it already being investigated as a drug.

The FDA decision was based on a provision in the Dietary Supplement Health and Education Act of 1994 (DSHEA) stating that a dietary supplement cannot contain an ingredient that has been “authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public”, unless the investigations began after the ingredient had been approved for use in supplements.

A request from a pharma company

The reason for the reversal is unknown, but as reported by Natural Products Insider, in December 2021, Metro International Biotech, a startup pharmaceutical company, wrote to the FDA: “As a company that has instituted publicly available clinical trials on ß-NMN, we request that FDA take the preclusion provision … seriously to protect the rights of companies that have spent significant time and research to develop drug products from competition from dietary supplements”. According to Insider, the FDA confirmed that it had considered Metro’s request.

Metro International Biotech, co-founded by Rajendra Apte and David Sinclair, is targeting several diseases with NAD+ precursors. It has developed a proprietary version of ß-NMN called MIB-626 and asked the FDA to approve its investigation as an investigational new drug (IND).

The earliest information about an MIB-626 trial found on ClinicalTrials.gov is dated September 2021. Apparently, at least two of the three criteria needed to trigger the exclusion clause were satisfied: MIB-626 is a subject of “substantial clinical investigations” that “has been made public”. However, it is not clear when exactly the drug was authorized for investigation. According to the FDA, this depends on when the IND authorization goes into effect, but surprisingly, the FDA does not disclose this information, and it also does not immediately become public.

Will the FDA enforce this?

The FDA can decide whether to enforce its own rulings on supplements. In a notable example, NAC (N-acetyl-L-cysteine), was excluded from the definition of a dietary supplement on similar grounds in 2021, but several months later, in response to an outcry that included citizen petitions and litigation, the FDA decided to exercise enforcement discretion with regard to NAC, effectively leaving its manufacturers alone for now.

While the law (DSHEA) does not provide a rationale for the exclusion clause, it appears like it is there solely to protect pharma companies that pour massive resources into investigating new drugs. However, some could see this as unfair towards supplement companies and their clientele. In this particular case, the companies were engaged in months of back-and-forth with the FDA, addressing various concerns and amending their proposals only to have them dismissed on entirely different grounds.

Currently, there is no sign of any NMN-containing supplements being taken off the shelves, and it is not clear whether the FDA will ultimately choose to enforce its ruling. Manufacturers of NMN supplements will likely continue pressing the FDA to exercise enforcement discretion, with Metro Biotech pulling in the opposite direction.

Metro Biotech did not respond to a request for comment. An FDA spokesperson contacted by Lifespan.io did not explain the rationale behind the exclusion clause, adding that the FDA “does not comment on whether or not it has or will commence enforcement actions.”

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Literature

[1] Imai, S. I., & Guarente, L. (2014). NAD+ and sirtuins in aging and disease. Trends in cell biology, 24(8), 464-471.

[2] Mills, K. F., Yoshida, S., Stein, L. R., Grozio, A., Kubota, S., Sasaki, Y., … & Yoshino, J. (2016). Long-term administration of nicotinamide mononucleotide mitigates age-associated physiological decline in mice. Cell metabolism, 24(6), 795-806.

[3] Yoshino, M., Yoshino, J., Kayser, B. D., Patti, G. J., Franczyk, M. P., Mills, K. F., … & Klein, S. (2021). Nicotinamide mononucleotide increases muscle insulin sensitivity in prediabetic women. Science, 372(6547), 1224-1229.

CategoryNews, Supplements
About the author
Arkadi Mazin

Arkadi Mazin

Arkadi is a seasoned journalist and op-ed author with a passion for learning and exploration. His interests span from politics to science and philosophy. Having studied economics and international relations, he is particularly interested in the social aspects of longevity and life extension. He strongly believes that life extension is an achievable and noble goal that has yet to take its rightful place on the very top of our civilization’s agenda – a situation he is eager to change.
  1. November 17, 2022

    Twitter is all abuzz about this being due to David Sinclair trying to patent NMN as a drug so he can profit from it/crowd out competition. This sounds quite dubious to me; between his academic appointments and various companies, I don’t believe he is hurting for money, and certainly not enough to risk alienating all the people inspired by him to make lifestyle changes and start taking sirtuin-affecting substances. Is there even a grain of truth to this idea?

  2. mevrspa
    November 17, 2022

    I the decision was more related to recent findings about NAD causing cancer especially TNBC and promoting brain metastasis. See: Warning: Popular Vitamin Supplement Causes Cancer Risk and Brain Metastasis.
    University of Missouri researchers made the discovery while using bioluminescent imaging technology to study how nicotinamide riboside supplements work inside the body.

    Commercial dietary supplements like nicotinamide riboside (NR), a form of vitamin B3, were linked to benefits related to cardiovascular, metabolic, and neurological health in previous studies. However, new research from the University of Missouri (MU) has found NR could actually increase the risk of serious disease, including developing cancer

  3. mevrspa
    November 17, 2022

    I the decision was more related to recent findings about NR causing cancer especially TNBC and promoting brain metastasis. See: Warning: Popular Vitamin Supplement Causes Cancer Risk and Brain Metastasis.
    University of Missouri researchers made the discovery while using bioluminescent imaging technology to study how nicotinamide riboside supplements work inside

  4. richierichness
    November 18, 2022

    I believe another lab is deliberately trying to taint the tests completed by Dr. Sinclair’s lab in order to overturn Metro Biotech findings, then present their own findings. In the business world this is what’s commonly known as a Hostile Takeover and often patents are at the root if the dispute eslecially in Biotech.

    FDA is being portrayed as complicit in this Takeover, but that remains unproven. Looks can be deceiving. There must be more to the plot here. Very challenging to understand why one company with one very limited study who are merely saying NMN may** cause brain cancer and metastis is being upheld as acceptable medical evidence without seeing the study in it’s entirety and subsequent independent studies. Wouldn’t surprise me if this study was merely the ploy of a delay tactic so another lab could present somewhat similar findings in search of a patent or trademark (or both) , instead of Metro Biotech International. FDA would be outside it’s jurisdiction meddling into any patent dispute IMHO. It must be said that the FDA has “illuminated” the very real possibility of a patent dispute, something that they have I’m sure, illuminated many times before.

    Shiploads of profit to be made by pharmaceutical companies here if they can somehow taint Dr. Sinclair’s research with mud that sticks if only to challenge an existing patent. Hostile indeed, look for the funny business around any synthetic NR, NMN, or NAD boosters. Not the NMN found in common foods of today. Precisely where pharmaceutical companies will see Dr Sinclair crossing the line into their domain, a financial threat. Synthetic drugs where billions if not $trillions are made is ultra competitive.

    By Dr Sinclair’s silence it’s near certain the devil is in the details now as to who discovered NMN’s miraculous benefits to longevity…. FIRST. Nicola Tesla’s invention of the telegraph was taken over by Marconi. Only after Tesla’s death was Marconi’s patent overturned by the Patent Office many years later. Just like the telegraph let’s hope this dispute over NMN as a safe molecule can be overturned for the benefit of mankind also, only much, much sooner and incredibly cheaper.

    Something is ROTTEN in the state of Denmark. May honesty and integrity prevail so more people can lead healthy, worthwhile lives economically.

    • jcaraguila50
      November 19, 2022

      I agree with you Doc
      I started taking NMN , 6 months ago and so far , my minor health problems had improve a lot, not to mention my social life.
      I need to mention I am taking it, in intervals of 3 months in between :)

    • francaluz
      November 20, 2022

      Dear Richard

      Thank you so much for your illuminating and in-depth thoughts on a ay times purposely confusing panorama. Much appreciated

      Be well

  5. forestresources
    November 18, 2022

    Dr. Sinclair’s relationship to the company doing “substantial research” as to the health benefits of b-NMN is of no concern to me as a private individual who wishes to use supplements in a way that benefits me. Dr. Sinclair should be ashamed of himself. Same thing happened to a natural substance *Chromium histidinate for known heart health benefits and was available in a product by Iceland Health Chromax Plus. That was sold to an entity that PATENTED Chromium histidinate and pulled the product off the shelves for the common, person. I am sick of this commercialization for private coffers!

  6. rwoodin3
    November 19, 2022

    Sinclair cofounded Metro International Biotech. That is the company that sent the exclusion request for NMN to the FDA. M.I.B. is the company that is developing the drug based on NMN. There’s no confusion or question about it. Sinclair and his company are cashing in on a potential new drug based on NMN, at the expense of everyone that uses NMN. This is after Sinclair made tons of money from books and speaking as a top, anti-aging scientist. Obviously, Sinclair is nothing more than a con man with a Phd. The mere fact that he has remained silent, speaks volumes.

  7. asadegb
    November 20, 2022

    Nicotinamide riboside is being banned? Now this was a form of vitamin B3. And I’m using a mic so forgive me I’m going to I may be all over the place. So this decision was made all from 1 study made in Missouri. A female scientist / doctor basically who is conducting this study with I believe it was 28 participants said that the anti-aging supplement was causing cancer, and basically she started this test after I believe her father or father-in-law or one of them it was a 56-year-old male that passed away from a cardiovascular disease, who is healthy; and the female was curious and wanted to study furthermore. Ever since then I’ve been seeing multiple articles come out about the same study, I mean people have been using this for years and have found it really really useful so I think they should do some more studies I don’t know how can they can just go off one study but people have been using this product for years and years what about that?

  8. fparsons2018
    November 22, 2022

    I have read the Lifespan book. There is no evidence of avarice in David Sinclair. I think it is best for all involved if he gains control of this drug. Go David !!!

    • kn63md
      November 24, 2022

      No avarice, but greed and clear conflicts of interest. But this appears the path to commercial success. The question at the end of the day is whether risks are outweighed by benefits. It would be nice to see greater transparency by the FDA.

      • Grace
        November 26, 2022

        That’s the world we live in, right? It would be nice to see transparency but that is highly doubtful. The FDA is nothing more than a tool of big pharma which is the epitome of greed. They don’t want supplements helping people live healthier, longer lives, especially any supplements that have more beneficial and dramatic results. Exact reason they tried to go after N-ACETYL CYSTEINE (NAC) during the pandemic. It works well in preventative protocols.

        If NMN did cause cancer, I truly believe the FDA would NOT tell people because treating cancer is far too profitable.

    • xpqu
      November 25, 2022

      I agree!

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